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Global Clinical Trials Playbook Capacity and Capability Building

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ISBN-10: 0124157874

ISBN-13: 9780124157873

Edition: 2012

Authors: Menghis Bairu, Richard Chin

List price: $125.00
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Description:

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium.Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step…    
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Book details

List price: $125.00
Copyright year: 2012
Publisher: Elsevier Science & Technology
Publication date: 5/30/2012
Binding: Hardcover
Pages: 320
Size: 8.46" wide x 10.87" long x 0.75" tall
Weight: 2.442
Language: English

Menghis Bairu, M.D.-physician, editor, author, philanthropist and healthcare business executive-has more than two decades of international experience in the biotechnology, pharmaceutical, global health and non-profit arenas. Dr. Bairu serves as Executive Vice President, Chief Medical Officer and Head of Global Development at Elan. His responsibilities include, but are not limited to clinical development, biometrics, regulatory, CMC, QA, safety-and-risk management, clinical operations and medical affairs. Previously he served as head of Onclave Therapeutics, a wholly Elan-owned oncology biotech company. He lectures extensively on global health and biopharmaceutical issues with particular…    

Richard Chin is the CEO of Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company and Associate Professor at UCSF School of Medicine. OneWorld Health develops affordable drugs for neglected patients in the developing world. Dr. Chin has extensive expertise in drug development, including over 45 INDs and almost a dozen drug registrations. His previous roles include CEO of a NASDAQ listed company, Senior Vice President of Global Development at Elan, and Head of Clinical Research for the Biotherapeutics Unit at Genentech. He was named by Businessweek in 2006 as one of the youngest 99 public company CEOs in the United States. Dr. Chin earned an M.D. from Harvard and the…    

Introduction
Global Clinical Trials: study design and planning
Building a healthy mechanism for GCP compliant global trials: African perspectives
Clinical Trial sites capabilities: effective African models
Strengthening / building clinical trial site capabilities and capacity in developing/emerging markets
How to select and oversee CROs
How to prioritize CTs based on national interest
The How to of Global Clinical Trial Forecasting, Budgeting, and Project Management
How to build-enhance Regulatory capacity to evaluate INDs and NDAs
Development of regulatory capacity in Monitoring, Oversight, Enforcement and approval of Clinical Trials
PharmacoVigilance and Risk Management
Setting up EDC capabilities
Ethics and IRB capacity building
Human resources planning and Job Descriptions
Ensuring intellectual property protection
Clinical Quality Assurance and Data Management
Appendices